FSMA 204 Compliance with V5 Traceability: Full Visibility of KDEs and CTEs
FSMA 204 is reshaping how food manufacturers, processors, and distributors manage traceability. With enforcement beginning January 2026, companies subject to the Food Traceability Rule must capture, maintain, and share specific Key Data Elements (KDEs) at defined Critical Tracking Events (CTEs)—from receiving and transformation to shipping and distribution.
V5 Traceability is built to meet this requirement head-on. By automating the capture of KDEs at every CTE, V5 eliminates the need for paper logs, disconnected systems, or delayed reporting. Whether you’re handling ingredients, work-in-progress, or finished goods, V5 ensures your records are accurate, immediate, and audit-ready—at every step of the supply chain.
What Is FSMA 204?
FSMA 204, also known as the Food Traceability Final Rule, is a key regulation issued under the Food Safety Modernization Act (FSMA) by the U.S. FDA. It requires companies handling certain high-risk foods to keep and share specific records—known as Key Data Elements (KDEs)—at defined Critical Tracking Events (CTEs). These include receiving, transformation, creation, and shipping steps throughout the supply chain.
The rule applies to foods listed on the FDA’s Food Traceability List (FTL), which includes:
- Fresh and cut fruits and vegetables
- Leafy greens, tomatoes, peppers
- Soft cheeses
- Shell eggs
- Nut butters and ready-to-eat deli salads
Timeline for Compliance
FSMA 204 was finalized in January 2023, with enforcement beginning January 20, 2026. By that date, all affected businesses must have electronic traceability systems in place to:
- Capture KDEs at each CTE
- Maintain 24-month electronic records
- Respond to FDA traceability data requests within 24 hours
Who Needs to Comply?
Many SG Systems customers fall under FSMA 204 scope if they handle FTL products or ingredients. This includes:
- Fresh produce packers and shippers
- Ingredient and dry mix blenders
- Deli salad, prepared food, or dairy processors
- Contract manufacturers and co-packers working with high-risk ingredients
Automated KDE Capture with V5
V5 automatically records all required KDEs during key manufacturing and handling events. As ingredients are received, stored, processed, or shipped, V5 logs the associated lot codes, supplier details, quantities, timestamps, responsible personnel, and locations—without relying on manual entry. These records are digitally signed, indexed, and immediately searchable by date, product, or batch ID.
“Before V5, traceability was a slow, manual process. Now every event is recorded as it happens. If FDA calls, we’re ready in minutes, not days.”
— VP of Quality, Prepared Foods Manufacturer
CTE Enforcement Through MES, QMS & WMS
V5 enforces every Critical Tracking Event with precision. In the Manufacturing Execution System (MES), all blend, mix, and packaging steps are validated in sequence. Quality Management (QMS) ensures COA verification, hold/release protocols, and deviation capture. The Warehouse Management System (WMS) tracks movement from receiving to staging, linking each step to digital identifiers and user accountability.
From receipt of raw goods to transformation and shipping, V5 ensures your process is fully mapped and compliant with traceability laws.
Built-in Reporting for FSMA 204 Response
If the FDA requests traceability data under FSMA 204, V5 can generate and export all KDEs associated with the affected lots in minutes. No spreadsheets. No binders. No delay. The system provides a chronological view of every CTE event and associated metadata—formatted for regulatory response within the 24-hour window.
Hardware Integration & ERP Sync with V5 Connect
Barcode scanners, printers, and weigh scales integrate directly with V5, ensuring KDEs are recorded with precision. PLCs and production equipment can trigger batch events and log critical data points automatically. V5 Connect links these inputs to your ERP—keeping master data aligned across purchasing, QA, inventory, and production.
“We stopped guessing about where ingredients came from and where they went. Now every movement is tracked and proven.”
— Plant Manager, National Food Group
Request a Demo: See FSMA 204 in Action
Want to see how V5 automates FSMA 204 traceability in your operation? Request a demo here and we’ll walk you through real-time KDE capture, trace reports, and CTE enforcement for your ingredients and batches—fully validated and audit-ready.
